Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04256707 · OUTCOME

Combination Therapy (Arms: A and B): Number of Participants With TEAEs

Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment · Source last updated 2026-10-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of study drug administration up to survival follow-up (up to 25 months)

What was measured

AE: Any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were any event that was not present prior to the initiation of study treatment, or any event already present that worsened in either intensity or frequency following exposure to study treatment.

Analysis population: Safety population included all participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods.

Groups in this outcome

Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel

Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks until PD or intolerable toxicity.

Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab

Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks until PD or intolerable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel17
Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab38

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel17Not reportedNot reportedNot reportedNot reported
Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab37Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        37
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      38
    units
    Participants
description
AE: Any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were any event that was not present prior to the initiation of study treatment, or any event already present that worsened in either intensity or frequency following exposure to study treatment.
groups
  1. description
    Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks until PD or intolerable toxicity.
    id
    OG000
    title
    Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel
  2. description
    Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks until PD or intolerable toxicity.
    id
    OG001
    title
    Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods.
reporting Status
POSTED
time Frame
From start of study drug administration up to survival follow-up (up to 25 months)
title
Combination Therapy (Arms: A and B): Number of Participants With TEAEs
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice